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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211601


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NDA 211601 describes TASIMELTEON, which is a drug marketed by Apotex, MSN, and Teva Pharms Usa Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the TASIMELTEON profile page.

The generic ingredient in TASIMELTEON is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.
Summary for 211601
Tradename:TASIMELTEON
Applicant:Teva Pharms Usa Inc
Ingredient:tasimelteon
Patents:0
Pharmacology for NDA: 211601
Mechanism of ActionMelatonin Receptor Agonists
Suppliers and Packaging for NDA: 211601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TASIMELTEON tasimelteon CAPSULE;ORAL 211601 ANDA Teva Pharmaceuticals, Inc. 0480-4490 0480-4490-56 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Dec 12, 2022TE:ABRLD:No

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